Manufacturers/Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC

165 drugs in NADAC|157 Generic,8 Brand

View Recalls (50)

Total Drugs

165

157G / 8B

Avg Price / Unit

$24.9219

$0.03 – $872.98

Avg 7d Change

-0.11%

Across 96 drugs with changes

7d Activity

514569 flat

of 165 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

Drug Portfolio

165 drugs total, 165 shown

Drug Price 7d Change
ADALIMUMAB-AACF(CF) PEN 40 MG/0.8 ML (2 PACK)
adalimumab
$872.9760
per EA
+0.06%
TYENNE 162 MG/0.9 ML AUTOINJCT
Tocilizumab-aazg
$821.7093
per ML
TYENNE 162 MG/0.9 ML AUTOINJCT
Tocilizumab-aazg
$821.7093
per ML
CHORIONIC GONAD 10,000 UNIT VL
Chorionic Gonadotropin
$285.7633
per EA
GLUCAGON 1 MG EMERGENCY KIT
Glucagon
$237.2221
per EA
+0.36%
GANIRELIX ACET 250 MCG/0.5 ML
Ganirelix Acetate
$62.3467
per ML
BORTEZOMIB 3.5 MG VIAL
Bortezomib
$43.3460
per EA
OCTREOTIDE 1,000 MCG/ML VIAL
OCTREOTIDE ACETATE
$41.7580
per ML
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
FOSAPREPITANT 150 MG VIAL
FOSAPREPITANT
$38.5080
per EA
VANCOMYCIN HCL 10 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$35.8586
per EA
VANCOMYCIN HCL 10 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$35.8586
per EA
VORICONAZOLE 200 MG VIAL
Voriconazole
$28.7741
per EA
ERTAPENEM 1 GRAM VIAL
Ertapenem Sodium
$28.3961
per EA
+5.82%
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN SULFATE
$26.4480
per EA
+4.84%
DAPTOMYCIN 500 MG VIAL
Daptomycin
$20.7686
per EA
DAPTOMYCIN 500 MG VIAL
Daptomycin
$20.7686
per EA
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
DESMOPRESSIN 40 MCG/10 ML VIAL
Desmopressin Acetate
$19.7990
per ML
+3.25%
DESMOPRESSIN AC 4 MCG/ML VIAL
Desmopressin Acetate
$19.7990
per ML
+3.25%
HALOPERIDOL DEC 100 MG/ML VIAL
HALOPERIDOL DECANOATE
$18.4466
per ML
+0.36%
HALOPERIDOL DEC 100 MG/ML VIAL
HALOPERIDOL DECANOATE
$18.4466
per ML
+0.36%
COLISTIMETHATE 150 MG VIAL
COLISTIMETHATE SODIUM
$16.3455
per EA
ENOXAPARIN 150 MG/ML SYRINGE
enoxaparin sodium
$15.3321
per ML
SUMATRIPTAN 6 MG/0.5 ML VIAL
Sumatriptan Succinate
$15.0000
per ML
ENOXAPARIN 120 MG/0.8 ML SYR
enoxaparin sodium
$14.8986
per ML
HALOPERIDOL DEC 500 MG/5 ML VL
HALOPERIDOL DECANOATE
$13.1360
per ML
-0.56%
HALOPERIDOL DEC 50 MG/ML VIAL
HALOPERIDOL DECANOATE
$12.1675
per ML
+4.33%
ENOXAPARIN 120 MG/0.8 ML SYR
Enoxaparin Sodium
$11.9737
per ML
-9.11%
ENOXAPARIN 300 MG/3 ML VIAL
enoxaparin sodium
$10.9742
per ML
-2.32%
ENOXAPARIN 150 MG/ML SYRINGE
Enoxaparin Sodium
$10.9407
per ML
-5.62%
ENOXAPARIN 40 MG/0.4 ML SYR
enoxaparin sodium
$9.8516
per ML
FLUPHENAZINE DEC 125 MG/5 ML
FLUPHENAZINE DECANOATE
$9.6988
per ML
-0.44%
ENOXAPARIN 30 MG/0.3 ML SYR
enoxaparin sodium
$9.6878
per ML
ENOXAPARIN 30 MG/0.3 ML SYR
Enoxaparin Sodium
$9.5701
per ML
+1.58%
ENOXAPARIN 30 MG/0.3 ML SYR
enoxaparin sodium
$9.5701
per ML
+1.58%
ENOXAPARIN 30 MG/0.3 ML SYR
Enoxaparin Sodium
$9.5701
per ML
+1.58%
ENOXAPARIN 80 MG/0.8 ML SYR
enoxaparin sodium
$9.3253
per ML
ENOXAPARIN 60 MG/0.6 ML SYR
Enoxaparin Sodium
$8.4061
per ML
+0.91%
ENOXAPARIN 60 MG/0.6 ML SYR
Enoxaparin Sodium
$8.4061
per ML
+0.91%
ENOXAPARIN 60 MG/0.6 ML SYR
enoxaparin sodium
$8.4061
per ML
+0.91%
ENOXAPARIN 60 MG/0.6 ML SYR
enoxaparin sodium
$8.4061
per ML
+0.91%
ENOXAPARIN 100 MG/ML SYRINGE
enoxaparin sodium
$8.1982
per ML
-4.13%
ENOXAPARIN 100 MG/ML SYRINGE
Enoxaparin Sodium
$8.1982
per ML
-4.13%
ENOXAPARIN 100 MG/ML SYRINGE
Enoxaparin Sodium
$8.1982
per ML
-4.13%
ENOXAPARIN 100 MG/ML SYRINGE
enoxaparin sodium
$8.1982
per ML
-4.13%
ENOXAPARIN 40 MG/0.4 ML SYR
Enoxaparin Sodium
$7.9043
per ML
-0.76%
ENOXAPARIN 40 MG/0.4 ML SYR
enoxaparin sodium
$7.9043
per ML
-0.76%
ENOXAPARIN 40 MG/0.4 ML SYR
Enoxaparin Sodium
$7.9043
per ML
-0.76%
HEPARIN SODIUM 20,000 UNIT/ML VIAL
HEPARIN SODIUM
$7.6218
per ML
ENOXAPARIN 80 MG/0.8 ML SYR
Enoxaparin Sodium
$7.6158
per ML
-3.20%
ENOXAPARIN 80 MG/0.8 ML SYR
Enoxaparin Sodium
$7.6158
per ML
-3.20%
ENOXAPARIN 80 MG/0.8 ML SYR
enoxaparin sodium
$7.6158
per ML
-3.20%
CEFAZOLIN 10 GM VIAL
Cefazolin Sodium
$7.2930
per EA
HEPARIN SODIUM 5,000 UNIT/0.5 ML SYRINGE
Heparin Sodium
$6.2736
per ML
-1.95%
ACETYLCYSTEINE 6 GRAM/30 ML VL
Acetylcysteine
$6.1376
per ML
EPHEDRINE SULFATE 50 MG/ML VL
Ephedrine Sulfate
$5.6366
per ML
MEROPENEM IV 1 GM VIAL
Meropenem
$5.5712
per EA
-4.57%
MEROPENEM IV 1 GM VIAL
Meropenem
$5.5712
per EA
-4.57%
CEFEPIME HCL 2 GRAM VIAL
Cefepime
$5.3480
per EA
OCTREOTIDE 1,000 MCG/5 ML VIAL
OCTREOTIDE ACETATE
$5.3404
per ML
+2.18%
ZOLEDRONIC ACID 4 MG/5 ML VIAL
Zoledronic Acid
$4.6828
per ML
METHYLPREDNISOLONE SS 125 MG
METHYLPREDNISOLONE SODIUM SUCCINATE
$4.1391
per EA
+2.13%
CEFEPIME HCL 1 GM VIAL
Cefepime
$3.7308
per EA
AZITHROMYCIN I.V. 500 MG VIAL
AZITHROMYCIN MONOHYDRATE
$3.5270
per EA
AZITHROMYCIN I.V. 500 MG VIAL
AZITHROMYCIN MONOHYDRATE
$3.5270
per EA
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
METHOTREXATE 250 MG/10 ML VIAL
METHOTREXATE SODIUM
$3.3484
per ML
-0.31%
HEPARIN SOD 5,000 UNIT/ML SYRG
Heparin Sodium
$3.3446
per ML
AMPICILLIN 2 GM VIAL
ampicillin sodium
$3.2338
per EA
OCTREOTIDE ACET 100 MCG/ML VL
OCTREOTIDE ACETATE
$2.8912
per ML
-2.25%
OCTREOTIDE ACET 100 MCG/ML VL
OCTREOTIDE ACETATE
$2.8912
per ML
-2.25%
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
HYDROMORPHONE 2 MG/ML VIAL
Hydromorphone Hydrochloride
$2.7866
per ML
-0.05%
AMIKACIN SULF 500 MG/2 ML VIAL
Amikacin Sulfate
$2.7228
per ML
HYDROMORPHONE 50 MG/5 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
+1.67%
HYDROMORPHONE 500 MG/50 ML VL
Hydromorphone Hydrochloride
$2.5663
per ML
+1.67%
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.5287
per ML
+5.11%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.4905
per ML
+2.80%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.4905
per ML
+2.80%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.4905
per ML
+2.80%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.3483
per ML
-1.69%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.3483
per ML
-1.69%
HEPARIN SODIUM 10,000 UNIT/ML VIAL
HEPARIN SODIUM
$2.2868
per ML
-1.61%
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$1.8983
per ML
PACLITAXEL 100 MG/16.7 ML VIAL
Paclitaxel
$1.8891
per ML
DEXAMETHASONE 10 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$1.8505
per ML
-4.26%
DEXAMETHASONE 10 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$1.8505
per ML
-4.26%
LORAZEPAM 2 MG/ML VIAL
Lorazepam
$1.7770
per ML
+5.54%
PACLITAXEL 300 MG/50 ML VIAL
Paclitaxel
$1.7700
per ML
KETAMINE 500 MG/5 ML VIAL
ketamine hydrochloride
$1.5655
per ML
+0.13%
PROGESTERONE 500 MG/10 ML VIAL
PROGESTERONE
$1.5401
per ML
-7.39%
CYANOCOBALAMIN 1,000 MCG/ML VL
CYANOCOBALAMIN
$1.5047
per ML
+0.17%
CYANOCOBALAMIN 1,000 MCG/ML VL
CYANOCOBALAMIN
$1.5047
per ML
+0.17%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.4501
per ML
-5.35%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.4501
per ML
-5.35%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone
$1.4287
per EA
+0.17%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$1.3184
per ML
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.2889
per ML
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.2889
per ML
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.2889
per ML
FENTANYL 2,500 MCG/50 ML VIAL
Fentanyl Citrate
$1.2480
per ML
+1.02%
FENTANYL 100 MCG/2 ML VIAL
Fentanyl Citrate
$1.2480
per ML
+1.02%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1361
per ML
+1.21%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1361
per ML
+1.21%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1361
per ML
+1.21%
FLUMAZENIL 0.1 MG/ML VIAL
FLUMAZENIL
$1.0656
per ML
+3.92%
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$1.0206
per ML
CEFAZOLIN 1 GM VIAL
CEFAZOLIN SODIUM
$0.9931
per EA
+0.66%
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.9656
per ML
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
DIPHENHYDRAMINE 50 MG/ML VIAL
DIPHENHYDRAMINE HYDROCHLORIDE
$0.9396
per ML
-0.49%
DIPHENHYDRAMINE 50 MG/ML VIAL
DIPHENHYDRAMINE HYDROCHLORIDE
$0.9396
per ML
-0.49%
GENTAMICIN 40 MG/ML VIAL
GENTAMICIN SULFATE
$0.9335
per ML
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$0.7688
per ML
+0.10%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.7389
per ML
+4.85%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.7389
per ML
+4.85%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.7389
per ML
+4.85%
DEXAMETHASONE 4 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.7294
per ML
-2.27%
DEXAMETHASONE 4 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.7294
per ML
-2.27%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6997
per ML
-1.99%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6997
per ML
-1.99%
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6417
per ML
-0.20%
DEXAMETHASONE 100 MG/10 ML VL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6317
per ML
-4.49%
TOBRAMYCIN 80 MG/2 ML VIAL
TOBRAMYCIN SULFATE
$0.6294
per ML
+4.97%
KETAMINE 500 MG/10 ML VIAL
ketamine hydrochloride
$0.5215
per ML
+0.03%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5086
per ML
+6.29%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5086
per ML
+6.29%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.5086
per ML
+6.29%
MIDAZOLAM HCL 50 MG/10 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.4500
per ML
DEXAMETHASONE 120 MG/30 ML VL
DEXAMETHASONE SODIUM PHOSPHATE
$0.4497
per ML
-3.37%
ZOLEDRONIC ACID 5 MG/100 ML
Zoledronic Acid
$0.4491
per ML
-3.38%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4049
per ML
+1.74%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4049
per ML
+1.74%
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.3500
per ML
+1.55%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.3500
per ML
+1.55%
TRANEXAMIC ACID 1,000 MG/10 ML
Tranexamic Acid
$0.3481
per ML
WATER FOR INJECTION VIAL
WATER
$0.3188
per ML
-0.54%
XYLOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2721
per ML
XYLOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2721
per ML
XYLOCAINE 2%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2655
per ML
DEXAMETHASONE 20 MG/5 ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.2381
per ML
DEXAMETHASONE 20 MG/5 ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.2381
per ML
MIDAZOLAM HCL 2 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.2345
per ML
-2.31%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1864
per ML
-1.45%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1864
per ML
-1.45%
ONDANSETRON 40 MG/20 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1585
per ML
-4.37%
SODIUM BICARBONATE 8.4% VIAL
Sodium Bicarbonate
$0.1540
per ML
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$0.1229
per ML
+0.14%
SENSORCAINE 0.5% VIAL
BUPIVACAINE HYDROCHLORIDE
$0.0977
per ML
SODIUM CHLORIDE 0.9% VIAL
SODIUM CHLORIDE
$0.0888
per ML
+1.01%
WATER FOR INJECTION VIAL
WATER
$0.0661
per ML
SODIUM CHLORIDE 0.9% VIAL
SODIUM CHLORIDE
$0.0584
per ML
BACTERIOSTATIC SALINE VIAL
SODIUM CHLORIDE
$0.0273
per ML

FDA Recalls (50)

Recalls matched by company name. Verify current status with FDA.

D-0432-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0427-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0431-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0429-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0425-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0433-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0434-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0436-2026
Ongoing
Class II

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0437-2026
Ongoing
Class II

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0435-2026
Ongoing
Class II

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0430-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0428-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0426-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0424-2026
Ongoing
Class II

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0182-2026
Ongoing
Class I

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Initiated: 11/6/2025
D-0127-2023
Terminated
Class II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0128-2023
Terminated
Class II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0129-2023
Terminated
Class II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0750-2022
Terminated
Class I

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Initiated: 3/4/2022
D-0245-2021
Terminated
Class I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 12/23/2020
D-0184-2021
Terminated
Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 12/17/2020
D-0172-2021
Terminated
Class II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Initiated: 12/10/2020
D-0120-2021
Terminated
Class I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

Cross Contamination with other products: trace amounts of lidocaine

Initiated: 11/17/2020
D-0105-2021
Terminated
Class III

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Initiated: 11/17/2020
D-1537-2020
Terminated
Class I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05

Cross Contamination with other products: trace amounts of lidocaine

Initiated: 7/22/2020
D-1391-2020
Terminated
Class III

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

Initiated: 7/13/2020
D-1296-2020
Terminated
Class I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 4/20/2020
D-1297-2020
Terminated
Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 4/20/2020
D-1489-2019
Terminated
Class I

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

Presence of Particulate Matter; glass particulates

Initiated: 6/28/2019
D-1386-2019
Terminated
Class III

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Failed Impurities/Degradation Specifications.

Initiated: 5/22/2019
D-0298-2019
Terminated
Class I

SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Initiated: 11/15/2018
D-0299-2019
Terminated
Class I

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Initiated: 11/15/2018
D-0426-2018
Terminated
Class III

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Initiated: 1/16/2018
D-0152-2018
Terminated
Class I

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Initiated: 10/27/2017
D-0647-2017
Terminated
Class III

Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

Subpotent Drug

Initiated: 3/16/2017
D-0456-2017
Terminated
Class II

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Failed Impurities/Degradation Specifications

Initiated: 12/16/2016
D-0866-2016
Terminated
Class II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.

Failed Impuities/Degradation Specifications

Initiated: 5/4/2016
D-0867-2016
Terminated
Class II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04

Failed Impuities/Degradation Specifications

Initiated: 5/4/2016
D-1037-2016
Terminated
Class II

Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37

Presence of Particulate Matter: Glass particulate found in sterile injectable product

Initiated: 4/25/2016
D-0818-2016
Terminated
Class III

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Initiated: 4/7/2016
D-0819-2016
Terminated
Class II

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

Initiated: 4/5/2016
D-1327-2015
Terminated
Class III

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Initiated: 7/28/2015
D-1234-2015
Terminated
Class II

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

Initiated: 6/4/2015
D-1114-2015
Terminated
Class II

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

Initiated: 4/28/2015
D-0290-2015
Terminated
Class II

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

Defective Container: Vials may be missing stoppers.

Initiated: 11/12/2014
D-1545-2014
Terminated
Class II

PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01

CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.

Initiated: 8/13/2014
D-1428-2014
Terminated
Class II

Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Initiated: 5/2/2014
D-1429-2014
Terminated
Class II

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Initiated: 5/2/2014
D-1148-2014
Terminated
Class II

Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.

Subpotent; 18 month time point

Initiated: 1/22/2014
D-379-2014
Terminated
Class III

FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11

Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

Initiated: 12/6/2013
Fresenius Kabi USA, LLC - Manufacturer Profile | NADAC Intelligence